RecruitingOBSERVATIONAL

Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population

This study is checking how a new heart valve, called Avalus, performs after it's been put into patients during heart surgery. It's for people who need their aortic valve replaced because it's narrowed (stenosis) or leaks (insufficiency). Doctors are simply observing patients who already receive this valve as part of their usual treatment, gathering information on how well they recover and how the valve functions over time. They want to see its effects in a wide range of everyday patients, helping us understand its safety and how effectively it works in the real world.

At a glance

Status

Recruiting

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrolment target

1,000

Start

10 Jun 2020

Estimated completion

31 Dec 2025

Aortic Valve Stenosis Aortic Valve Insufficiency

What is this study about?

This study, called the Avalus European Registry, is looking at how a new heart valve performs in patients who have already had it fitted as part of their standard treatment. It focuses on the 'Avalus' heart valve, which is used to replace a faulty aortic valve. The aortic valve is one of the main valves in your heart, and if it's not working correctly – either because it's too narrow (aortic stenosis) or it's leaking (aortic insufficiency) – it can cause serious health problems. Replacing it with an artificial valve, like the Avalus, is a common treatment.

Doctors want to understand the real-world experiences of people who have received the Avalus valve. They are observing a large number of patients across Europe (and possibly Canada) to see how well the valve works, how safe it is, and how patients recover after their surgery. This kind of study is 'observational,' meaning patients aren't given a new treatment specifically for the study; instead, doctors are simply collecting information on those who have already received the Avalus valve as part of their normal care.

The main goal is to gather detailed information about the valve's performance and impact on patients after surgery. This helps medical experts understand if the valve is truly effective and safe for a wide variety of patients, giving them a clearer picture beyond what is learned in initial tests. They are collecting information for up to a year after the surgery.

Key takeaways

This study observes the Avalus heart valve after routine replacement surgery.
It helps doctors understand how the valve performs in real-world patients.
Participation means allowing your medical information to be collected during regular follow-ups.
You won't receive extra treatments or procedures due to the study.
The study aims to include many different types of patients for a broad view.
Results could help improve future care for people needing valve replacements.

Who may be eligible?

To be included in this study, you must be 18 years old or older. You would also need to have a clinical reason for needing to replace your aortic valve – either because your natural valve isn't working properly or an artificial valve you already have needs replacing – and the Avalus valve is chosen for you.

Crucially, you would need to be well enough to understand what taking part involves and be able to give your consent (permission) to have your information included. Since this valve is already in use, taking part mainly means allowing doctors to record information about your health and how the valve performs after your surgery.

There are very few reasons why you might not be included. If you’re under 18, you can’t take part. Also, if you need emergency, life-saving surgery where doctors don't have time to get your consent, you wouldn't be included in this study. Otherwise, the study aims to include as many different types of patients as possible to get a broad understanding of the Avalus valve's performance.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I 18 years old or older?
Do I need my aortic valve replaced, and will the Avalus valve be used?
Can I understand the study information and give my permission to take part?
Am I NOT having emergency, life-saving heart surgery right this moment?

Answer every question to see your result.

What does participation involve?

If you participate in this study, you won't be undergoing any extra procedures or taking different medication specifically for research. Instead, doctors will simply collect information from your medical records about your health and how your Avalus heart valve is working. This happens during your regular check-ups and follow-up appointments after your valve replacement surgery. They will monitor your progress for up to one year following your operation. Your involvement is mostly about allowing your health information to be recorded for the study, helping researchers understand the valve's real-world performance.

Potential risks and benefits

Since this is an observational study, you won't be exposed to any additional risks from the research itself, beyond the usual risks associated with your heart valve replacement surgery. The Avalus valve is already approved for use in patients. The main benefit of participating is knowing that the information gathered from your experience can help doctors and researchers better understand how the Avalus valve works in diverse, real-world patients. This understanding can improve future care for others. You are free to withdraw your consent for your data to be used at any time without it affecting your medical care.

Locations (19)

UZ Leuven
Verified postcode
Leuven, Belgium· Recruiting
UCL St Luc
Verified postcode
Brussels, Belgium· Recruiting
ZOL
Verified postcode
Genk, Belgium· Recruiting
AZ Maria Middelares
Verified postcode
Ghent, Belgium· Recruiting
UZ Gent
Verified postcode
Ghent, Belgium· Recruiting
Rigshospitalet
Verified postcode
Copenhagen, Denmark· Recruiting
Kuopio University Hospital
Verified postcode
Kuopio, Finland· Recruiting
CHU Nantes
Verified postcode
Nantes, France· Recruiting
Schüchtermann-Klinik
Verified postcode
Bad Rothenfelde, Germany· Recruiting
Universität Herzzentrum
Verified postcode
Hamburg, Germany· Recruiting
Osp. S.Orsola Malpighi
Verified postcode
Bologna, Italy· Recruiting
Fondazione Poliambulanza
Verified postcode
Brescia, Italy· Recruiting

Common questions

What is the Avalus European Registry?

It's a study observing how patients who receive the Avalus heart valve for a faulty aortic valve are doing after their surgery.

Why is this study being done?

Doctors want to understand the safety and performance of the Avalus heart valve in a wide range of patients receiving it as part of their routine care.

Do I get a special treatment if I join?

No, you'll receive the standard Avalus valve replacement surgery. The study simply collects information about your recovery and the valve's performance.

How long will I be involved?

Your progress will be observed and recorded for up to one year after your heart valve surgery.

Can I decide not to participate?

Yes, you have the right to decide not to have your information included in the study, and your medical care will not be affected.

How to find out more

Bart Meuris

bart.meuris@uzleuven.be +32 16 344260 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.